A Pilot Study About The Effects of Indirect-Moxibustion on Bladder- Functional Improvement and Symptoms Management in Patients With Overactive Bladder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Overactive bladder-validated 8-questions
研究概览
简要总结
This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on overactive bladder (OAB) patients.
详细描述
Patients who diagnosed as overactive bladder aged 20 to 75 years old will be divided into two groups, one is moxibustion-therapy and the other is waiting-list group.
Patients who belong to moxibustion therapy group will be treated moxibustion for 12 times by a Korean Medicine doctor.
Patients who belong to waiting-list group will be prohibited to get any treatment including moxibustion for relieve the symptoms of overactive bladder, and the same moxibustion therapy with moxbiustion-therapy group will be conducted after 4 weeks.
Overactive bladder symptom score (OABSS), overactive bladder-validated 8-question (OAB-V8) will be measured to evaluate the effectiveness.
The number of side effect will be measured to evaluate the safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged from 20 to 75 years old
- •submit written consent
- •no deficit to notify the hotness promptly and exactly
- •diagnosed with overactive bladder
- •suffering the OAB symptoms during greater than or equal to 3 months
排除标准
- •obstructive disease of urinary tract
- •cystocele, vaginocele or rectocele
- •urinary tract infection finding on urine analysis
- •diabetic mellitus
- •sensory disturbance
- •pregnancy, possibility of pregnancy or planning to pregnancy
- •problems to communication due to any medical problem such as cognitive dysfunction
- •getting other treatment of either Traditional Korean Medicine or conventional medicine for overactive bladder
- •psychiatric disorder or severe systemic disease.
结局指标
主要结局
Overactive bladder-validated 8-questions
时间窗: 4 weeks
This is to measure how the patients have been bothered by OAB.
次要结局
- The skin temperature of CV4, SP6 and LR3(4, 8 weeks)
- Overactive bladder symptom scores(4, 8 weeks)
研究者
JUNGNAM KWON
Professor
Korean Medicine Hospital of Pusan National University